▎WuXiEdited by Kant Content Team

LENZ Therapeutics Announces Positive Results from Phase 3 CLARITY Trial of Two Aceclidine Eye Drop Formulations for Presbyopia TreatmentThe near vision of patients can be significantly improved within 30 minutes after using the eyedrops, and the effect can last for 10 hours! This means that as long as the patient applies a few drops in the morning, their near vision can be improved for almost the entire day!The analysis also showed that LNZ100 demonstrated superiority over LNZ101. Based on these positive results, LENZ Therapeutics expects to submit the New Drug Application (NDA) for LNZ100 by mid-2024.

CLARITY is a Phase 3, multicenter, double-blind, randomized study evaluating the efficacy and safety of LNZ100 and LNZ101 in treating presbyopia. It consists of two six-week efficacy trials, CLARITY 1 and 2, and a six-month safety trial, CLARITY 3.

▲CLARITY 1 and 2 Trial Design (Source: Reference [2])

The analysis shows,LNZ100 (1.75% aceclidine) met the primary endpoint and key secondary endpoints of the trial, demonstrating an improvement of more than 3 lines (15 letters) on the near vision chart without losing 1 line (5 letters) of distance vision.In the CLARITY 2 trial with solvent control, the results on Day 1 of the trial showed that LNZ100 demonstrated the following effects:

▲LNZ100 Achieves Primary Endpoint of the Trial(Image source: Reference [2])

• Fast-acting:71% of patients achieved an improvement of three lines or more on the eye chart within 30 minutes.（p<0.0001）。

• Reach the primary endpoint:71% of patients achieved three or more lines of improvement on the eye chart within 3 hours.（p<0.0001）。

• Long duration:40% of patients achieved an improvement of three lines or more on the eye chart within 10 hours.（p<0.0001）。

• During the four-week study period, the improvement in near vision demonstrated by patients in the CLARITY-1 and CLARITY-2 trials was reproducible and consistent.

• LNZ100 was well-tolerated, with no serious treatment-related adverse events observed over more than 30,000 treatment days across the three CLARITY trials.

  
  

▲LNZ100 Demonstrates Good Tolerability(Image source: Reference [2])

LNZ101 also showed similar results in the trials, including achieving both primary and secondary endpoints in CLARITY 1 and 2, but did not demonstrate superiority over LNZ100. Based on these results,LENZ Therapeutics Chooses LNZ100 as Its Lead Candidate Product.

▲LNZ100 Selected as the Main Product(Image source: Reference [2])

LNZ100 (Aceclidine) and LNZ101 formulation (Aceclidine + Brimonidine) developed by LENZ Therapeutics both use Aceclidine as the main ingredient.Aceclidine is a small-molecule acetylcholine receptor agonist that induces pupil constriction, creating a pinhole effect to improve near vision. Compared with other cholinergic receptor agonists, it exhibits higher specificity in its action on the iris muscles that control pupil size. This specificity reduces ciliary muscle contraction while constricting the pupil, minimizing changes in the lens' refractive power and thereby avoiding adverse effects on the patient's distance vision.

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